Recipient: Terumo Cardiovascular Systems.
Product:Advanced Perfusion System (APS-1)
Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806. For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm to reduce a risk to health posed by the APS-1 device. This field correction included a software update to correct a software defect that could result in incomplete delivery of cardioplegia dose. CDRH evaluation has classified your October 19, 2005 notification to consumers of a software upgrade as a Class II recall indicating a situation in which use of or exposure to the APS-1 presents a remote probability of serious adverse health consequences.
FDA District:Detroit District Office